无菌三级手术服
K号: K211399 · 2022-07-22
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决定日期2022-07-22
产品代码FYA
咨询委员会SU
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决定实质等同
器械摘要
Sterile Level 3 Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Barco Tekstil Sanayi VE Ticaret A.S.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K211399. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sterile Level 3 Surgical Gown?
Sterile Level 3 Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Barco Tekstil Sanayi VE Ticaret A.S.. The 510(k) number is K211399.
When did Sterile Level 3 Surgical Gown receive FDA 510(k) clearance?
Sterile Level 3 Surgical Gown received FDA 510(k) clearance on 2022-07-22, under 510(k) number K211399.
Who is the listed applicant for Sterile Level 3 Surgical Gown?
The FDA 510(k) record lists Barco Tekstil Sanayi VE Ticaret A.S. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sterile Level 3 Surgical Gown?
The FDA product code for Sterile Level 3 Surgical Gown is FYA.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：FYA）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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